Quality
Certifications and inspection
Medical and industrial buyers need a molder whose processes are validated and whose lots are traceable. That is how we run every program.
ISO 13485:2016
Medical device quality management system, registered since 2014.
ISO 9001:2015
Quality management system for all industrial and consumer programs.
ISO Class 8 Cleanroom
Certified cleanroom for medical and pharmaceutical molding, monitored continuously.
FDA Registered
Registered establishment for medical device component manufacturing.
Inspection and traceability
How we prove it
- Process validation to IQ, OQ, and PQ for regulated programs
- Scientific molding with documented process windows
- CMM and vision inspection with SPC on critical dimensions
- Full lot traceability from resin to shipment
- PPAP and first article reports for automotive and OEM work
Need our certificates for your supplier file?
Request a quote and ask for the quality package. We send certificates and scope with every new customer.